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Friday, October 26, 2007

If you’re into gene therapy, China’s the place to be. While this area remains, in the Western markets, a future promise (albeit one looking likelier to deliver than it ever has, as we reported in START-UP), in China’s it’s happening today. The only two firms with commercial gene therapy products are Chinese; both have had their drugs on the market for several years with, so far, no sinister effects—at least, none we’ve heard about.

Small wonder, then, perhaps, that Genzyme—one of the few larger players to have stuck doggedly with gene therapy where others fled—yesterday announced a tie-up with one of these Chinese pioneers, Sunway Biotech Co., to develop and commercialize Genzyme’s Phase II drug Ad2/HIF-1a, an engineered form of the HIF-1a gene designed to promote the growth of new blood vessels in patients with peripheral arterial disease.

Sunway will design, fund and run Phase I and Phase II trials in China in limb ischemia; the partners will share Phase III costs and eventual commercialization rights. There aren’t any disclosed financials, but it’s got to be good for privately-owned Sunway, which has been selling its own adenoviral-based head and neck cancer therapy H101 for two years. It gets Genzyme’s product manufacturing process (so that it can produce the drug in its Shanghai facility), a latish-stage CV product, and the kudos of a deal with an established Western player.

For Genzyme, the deal isn’t just about tapping the experience of a player who, for whatever reasons—let’s not get into Chinese regulatory standards--has been among the first to sell a gene therapy drug. It’s not just about getting a foot into the one market where Genzyme knows this particular drug has a fair chance of getting past the regulators.

No, this is about getting into China full stop. “Our work with Sunway represents one of many ways we hope to participate in the dynamic Chinese biotech industry and contribute to its growth,” confirms Genzyme EVP Duke Collier.

Now granted, for all the excitement over China, it’s not all good. US-based Introgen claims, for instance, that SiBiono, the other firm with a marketed gene therapy in China, copied its own lead candidate Advexin, which has been crawling towards US submission for the last few years. Gendicine, which uses an adenovirus to deliver the p53 tumor suppressor gene, does indeed look mighty similar to Advexin.

So sure, China’s not so hot on IP enforcement; the Asian dragon gave just a “diplomatic nod” towards patent rules when it the joined the WTO in 2001, according to one executive. And its bribery and corruption record isn’t squeaky clean either (whose is?); the fact that penalty includes the death sentence---a former top regulator was sentenced and executed earlier this year--doesn’t exactly make the picture any less sordid.

But the end market in China, comprising 1.3 billion people (and growing), is simply too big to miss out on—for gene therapy just like any other area of medicine. So is the prospect of a budding Chinese biotech industry. That’s why most Big Pharma have operations there—not just manufacturing or clinical trial centers, but increasingly, R&D. It's also why Genzyme wants in.

And in partnering with Sunway, Genzyme's taking in the early lesson from these forays: getting in with the locals. “If you don't have the right relationships [with locals] it's difficult to do anything," says Lee Babiss, head of pharma research at Roche. Roche claims the crown for establishing the first wholly-owned R&D center in China almost four years ago--an investment that, as well as giving it access to Chinese scientists, has brought Roche an influential 'in' with local lawyers, government officials and ministers in charge of steering the sector’s growth and upholding standards.

Tellingly, Introgen isn’t bothering to litigate against SiBiono (it has got enough on its plate); instead, “we’re in discussions with more mature pharmaceutical marketers in China,” says CEO David Nance. Expect more Chinese players to feature in our dealmaking databases, and not just in gene therapy deals.

3 comments:

Anonymous
said...

A couple of comments. 1/China has at least 3 gene therapies approved (if not more). On September 12 2006, angiogenic inhibitor Endostar (recombinant human endostatin) developed by Medgenn, based in Yantai, Shandong Province was approved for non-small cell lung cancer. Endostar isa Chinese version of endostatin, which was discontinued by EntreMed in 2003 and which has been modified.

2/It seems a bit gratuitous to throw comments about non-respect of IP status. I am not familiar with the status of SiBiono's therapy vis-a-vis Introgen's but it seems to be a bit obvious that a US competitor would be heavily tempted suggest that their product has been copied by their Chinese rival (who is ahead of them reaching the market) because everybody in the West would be enclined to believe them.

The CEOs of the Chinese biotech companies who have managed to launch gene therapy products on the Chinese market are typically very aware of IP issues and very international in their outlook.

They know it is in their best interest, in the long term, to have a clear IP status, especially since the courts have started coming down heavily on company not respecting IP in China (a case involving giving a heavy fine to a Chinese company making copies of Viagra opened the door to more IP enforcement).

An example of awareness of IP issues comes from Sunway Biotech. Sunway's H101, for example,is essentially a modified version of Onyx-015, initially developed by Onyx Pharmaceuticals,and dropped in 2003. Sunway Biotech, dealt with the IP issue by first obtaining a patent for the oncolytic virus, which Onyx did not apply for in China. And then,in January 2005, Sunway Biotech obtained a license for Onyx-015 from Onyx in a deal worthup to an estimated $10 million.

Thank you for your comments. I'd argue that Endostar isn't a gene therapy..but yes there are other examples of novel biologics being launched first in China.On your second point: Introgen isn't the only one to have raised concerns about Chinese IP enforcement...I think the issue here is as much different interprentations of patent law by local courts/judges, as in INdia, as anything else. Yes, Introgen will have their position...they can give more detail...but as I mention, the fact that they're not fighting it says something. I'm sure you're right that Chinese biotech CEOs are very aware of IP issues. It will boil down to how these are interpreted just as occurs in the West, look at Roche/Amgen. Thank you for pointing out the Sunway/Onyx link.

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